Inflectra Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 0069-0809

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Inflectra (NDC 0069-0809). A significant event, classified as Class II, was initiated on Jan 17, 2025 by Pfizer Laboratories Div Pfizer Inc. The reported reason for this action was: "cGMP Deviations: Product intended for quarantine was inadvertently distributed."

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0213-2025ONGOING

January 2025 Class II Recall: cGMP Deviations

Recall Number
D-0213-2025
Class II Ongoing
Reason for Recall
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Initiated
Jan 17, 2025
Reported
Feb 05, 2025
Quantity
192 vials

Recall Profile & Regulatory Data

Event ID
96167
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
McKesson
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Product Description
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01
Batch or Lot Expiration Information
Lot# 04647349, Exp Date 5/31/2029
Affected Packages Involved in this Recall
0069-0809-01Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.